FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CORE NEEDLE BIOPSY
K Number: K040266
·
Decision Jul 9, 2004
Classifications
1
FEI Numbers
207
Registration Numbers
207
Same Product Code
360
Applicant Total
19
Review Days
155
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Basic Information
- Device Name
- CORE NEEDLE BIOPSY
- K Number
- K040266
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.1075
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Remington Medical, Inc.
- Date Received
- February 5, 2004
- Decision Date
- July 9, 2004
- Product Code
- KNW
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KNW | Instrument, Biopsy | FDA class 2 | Gastroenterology, Urology |
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| K Number | Device Name | ||
|---|---|---|---|
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| K211589 | VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger | Jan 27, 2022 | Substantially Equivalent |
| K212065 | VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger | Oct 7, 2021 | Substantially Equivalent |
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| K150266 | Remington Medical Inc. Tuohy Epidural Needles | Jun 4, 2015 | Substantially Equivalent |
| K130282 | REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT | May 13, 2013 | Substantially Equivalent |
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